Events

Retiro De Equipo (Recall) de S&N Birmingham Hip Modular Head, 36mm to 62mm

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Orthopaedics Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18345
  • Fecha de inicio del evento
    2015-04-16
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Causa
    In october 2012, smith & nephew issued a hazard alert informing surgeons and hospitals that the birmingham hip™ modular head had been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in late 2014, smith & nephew became aware of new information relating to the performance of bhmh. also, recent registry and clinical data has showed a decline in the performance of the bhmh., based on the analysis of this information, smith & nephew considers that patients implanted with the bhmh device may be at greater risk of revision surgery.
  • Acción
    Manufacturer to issue advice regarding use

Device

S&N Birmingham Hip Modular Head, 36mm to 62mm
  • Modelo / Serial
    Model: Catalogue Numbers: 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd